• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE BORDEAUXREFLEX-HYBRID 1 LEVEL ACP SIZE 12MMIMPLANT

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER SPINE BORDEAUX REFLEX-HYBRID 1 LEVEL ACP SIZE 12MM IMPLANT   Back to Search Results
Catalog Number 48651112
Event Date 12/19/2008
Event Type  Malfunction   Patient Outcome  Other
Event Description

It was stated, "during the revision of a one-level reflex hybrid case, the top left screw was removed with a small metal shard coming off of the locking ring. During the backing out of the upper right screw, the plate came over the top of the lower left screw. With the plate being loose at the distal end, the second screw was difficult to get out. After the plate with the third screw (lower right) still locked in was removed, the fourth screw (bottom left) was then removed from the vertebral body. ".

 
Manufacturer Narrative

Additional information has been requested, and if made available, will be reported in a supplemental. Method, result, and conclusion codes will be made available following engineering evaluation.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameREFLEX-HYBRID 1 LEVEL ACP SIZE 12MM
Type of DeviceIMPLANT
Manufacturer (Section F)
STRYKER SPINE BORDEAUX
cestas
FRANCE 33610
Manufacturer (Section D)
STRYKER SPINE BORDEAUX
cestas
FRANCE 33610
Manufacturer (Section G)
STRYKER SPINE BORDEAUX
zone industrielle de marticot
cestas
FRANCE 33610
Manufacturer Contact
harry hunt
2 pearl court
allendale , NJ 07401
(201) 760 -8116
Device Event Key1490678
MDR Report Key1368104
Event Key1304935
Report Number9617544-2009-00019
Device Sequence Number1
Product CodeKWQ
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Remedial Action Other
Type of Report Initial
Report Date 12/30/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/06/2009
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number48651112
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? No
Date Manufacturer Received12/30/2008
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 02/06/2009 Patient Sequence Number: 1
#TreatmentTreatment Date
NA
-
-